Public Health

A former farm worker named Enrique Rubio may just be the right “David” to take down “Goliath” chemical company Monsanto. Rubio filed suit against the manufacturer of Roundup® early last week, claiming that the company’s infamous herbicide is the cause of his bone cancer and inability to work.

Roundup’s® safety has been hotly debated for years among scientists, environmental activists and those concerned with human health. Rubio’s suit, if successful, may put an end to that debate once and for all by forcing Monsanto to provide proof that it knowingly withheld data on the true dangers of its flagship product.

The active ingredient in Roundup®, a nasty chemical called glyphosate, was discovered in 1970. Rubio’s suit states that [g”]lyphosate is a broad-spectrum, non-selective herbicide used in a wide variety of herbicidal products around the world. Plants treated with glyphosate translocate the systemic herbicide to their roots, shoot regions and fruit, where it interferes with the plant’s ability to form aromatic amino acids necessary for protein synthesis. Treated plants generally die within two to three days. Because plants absorb glyphosate, it cannot be completely removed by washing or peeling produce or by milling, baking, or brewing grains.”

Monsanto claimed glyphosate was “a technological breakthrough: it could kill almost every weed without causing harm either to people or to the environment.” However, that doesn’t seem to be the case. The World Health Organization (WHO) asserts that glyphosate is “a probable cause of cancer.”

Why would Monsanto take such a big risk? Money. The company needed a win in the industry in order to continue its “reputation and dominance in the marketplace. Largely due to the success of Roundup® sales, Monsanto’s agriculture division was out-performing its chemicals division’s operating income, and that gap increased yearly.” So, rather than go with a less toxic product, Monsanto sold humanity and the planet for its own bottom line.

Wait, a less toxic product? Is that possible? Indeed, it is possible and was possible from Day One. “The harm caused by [Monsanto’s] Roundup® products far outweighed their benefit. …Roundup® products were and are more dangerous than alternative products and {the company] could have designed its Roundup® products to make them less dangerous. Indeed, at the time that [Monsanto] designed its Roundup® products, the stat of the industry’s scientific knowledge was such that a less risky design or formulation was attainable.”

So basically, Monsanto decided it was better (for it) to release a carcinogenic product that it was to spend a bit more money taking the time to research a less harmful alternative. The sad thing is, knowing that its product was dangerous, Monsanto had to pull some serious strings to get it approved.

The EPA originally classified glyphosate as “possibly carcinogenic to humans” in 1985. However, “after pressure from Monsanto, including contrary studies it provided to the EPA, the EPA changed its classification to evidence of non-carcinogenicity in humans in 1991.”

The “contrary studies” involved two “independent” labs that willfully committed scientific fraud. The FDA inspected one lab, Industrial Bio-Test Laboratories (IBT), in 1976. That inspection uncovered “discrepancies between the raw data and the final report relating to the toxicological impacts of glyphosate.”

This prompted the EPA to do its own audit. The EPA found the same results. Moreover, one EPA reviewer said that, “after finding ‘routine falsification of data’ at IBT, that it was ‘hard to believe the scientific integrity of the studies when they said they took specimens of the uterus from male rabbits.’” Unsurprisingly, three of IBT’s top executives were convicted of fraud in 1983.

The other lab, Craven Laboratories, was hired by Monsanto to perform additional tests on glyphosate in 1991. “In that same year, the owner of Craven Laboratories and three of its employees were indicted, and later convicted, of fraudulent laboratory practices in the testing of pesticides and herbicides.”

According to Rubio’s complaint, “Despite the falsity of the tests that underlie its registration, within a few years of its launch, Monsanto was marketing Roundup® in 115 countries.” Nowadays, Monsanto’s glyphosate products can be found in 130 countries and are approved for use on over 100 different crops. If you think that you’re safe, think again.

“[Glyphosate products] are ubiquitous in the environment. Numerous studies confirm that glyphosate is found in rivers, streams, and groundwater in agricultural areas where Roundup® is used. It has been found in food, in the urine of agricultural workers, and even in the urine of urban dwellers who are not in direct contact with glyphosate.”

The New York Attorney General sued Monsanto in 1996 claiming its Roundup® advertising was “false and misleading.” The suit specifically challenged “Monsanto’s general representations that its spray-on glyphosate-based herbicides, including Roundup®, were ‘safer than table salt’ and ‘practically non-toxic’ to mammals, birds, and fish.”

Monsanto agreed, in 1996, to “cease and desist from publishing or broadcasting any advertisements [in New York].”

Various other governments have either severely restricted or outright banned the sale of Roundup®, including the Netherlands, Brazil, France, Bermuda, Sri Lanka and Columbia.

Indeed, this may be the beginning of the end for Monsanto and Roundup®. One can only hope that justice will prevail in Rubio’s case and the chemical giant will be forced to tell the truth and face the consequences.

Recently, Reuters reported that “Drug companies generally don’t disclose all the reasons new medicines fail to win U.S. marketing approval, even though regulators often reject treatments over concerns about safety or effectiveness”.

Reporter Lisa Rapaport quotes Dr. Peter Lurie, FDA associate commissioner for public health strategy and analysis, saying “‘Only a minority of the press releases clearly stated that receipt of a complete response letter meant that marketing could not commence, and most findings associating the drug with a higher mortality rate went unmentioned.’” (emphasis added)

In her report, Rapaport notes that Dr. Lurie reviewed announcements by pharmaceutical companies following FDA disapproval released between 2008 and 2013 and found that “About half of the time, the complete response letters cited shortcomings in both safety and effectiveness. Out of 191 concerns about effectiveness raised in the letters, drugmakers disclosed a total of 30 in press releases, while companies shared 22 of 150 safety concerns.

Roughly half of the letters asked for new clinical trials to study safety or effectiveness; and in 59 percent of these cases companies disclosed this in a press release.”

This practice makes intuitive sense for drug companies, however cynical it is to admit. Why would pharma companies want to disclose precisely how a proposed product failed to meet FDA safety and efficacy requirements?

This actually raises an important issue for the FDA: should all proposed pharmaceutical products, not only approved drugs and devices, be a part of public knowledge? Companies whose stock is traded on the open market are already required to detail drug rejections (as is noted in the aforementioned Reuters piece), but not all drug companies are publicly held. Privately-held pharmaceutical corporations will argue that disapproved compounds consist in proprietary knowledge, and they may be right, public health concerns aside.

It nonetheless still is important to consider drugs that “may have been,” (or rather, drugs that failed to surmount the ever-weakening FDA approval process). Many drugs sold in America are disapproved upon initial FDA review, and following simple adjustments to study design, methodology, or statistical rigour are approved without meaningful changes to drug design. That is, the method used to test a drug’s effectiveness or safety can be adjusted, and a disapproved drug is made legal, without change to a drug’s chemical design.

With attention paid to disapproved drugs through open communication between pharmaceutical companies, the FDA, and the American public, consumers can understand more completely whether substantive changes were made to a drug’s design between initial disapproval and subsequent approval.

By no means would I suggest it is necessary, or would even be helpful, that the American populous attempt a measure of biochemical or pharmacological scrutiny when reviewing the FDA’s news ticker. That is the task of science journalists and healthcare analysts. As long is information regarding drug disapproval is available in full, dissemination to the public is possible, and that is a good thing.

Recently, a craniofacial distraction implant by DePuy Orthopaedics was recalled. This device, called the Craniomaxillofacial (CMF) Distraction System, “is a modular family of internal distraction devices that are used to gradually lengthen the mandible body and ramus” and indicated as “a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus, where gradual bone distraction is required,” for children less than one year old.

However, the FDA writes that “Infants are at the highest risk for injury if the device fails because sudden obstruction of the trachea can occur. This could lead to respiratory arrest, and result in death.” (emphasis added)

Again according to the FDA, “DePuy Synthes is recalling certain lots because the device may reverse direction and lose the desired distraction distance after surgery”, noting that “children or adults with the ability to maintain an open airway are at less risk for serious injury because failure of the device would not result in tracheal obstruction and could be medically reversible.”

Importantly, it is made clear that “In all patient populations, failure of the device may result in the need for surgical intervention to replace the failed device.”

To-date, fifteen people have been injured due to failure of the CMF Distraction System.

If you or a loved one used a CMF Distraction System and suffered injury as a result, you may be entitled to significant financial compensation through a CMF Distraction lawsuit. For a free, no-obligation case consultation, contact our team of CMF Distraction lawyers at the information provided below. We have the experience, resources, and skills required to win the justice you deserve. Call today and see how we can help.

The defendant companies are USPLabs, LLC (“USPLabs”) and General Nutrition Center Holdings Inc. (“GNC”). USPLabs sells a variety of energy and weight loss dietary supplements under the brand name of OxyElite Pro through GNC.

The complaint was filed in the U.S. District Court for the District of New Jersey. In it, Plaintiff Barot says he bought and used OxyElite Pro supplements while living in New Jersey between March 2010 and October 2011. He says he bought the product at a GNC store. Barot says OxyElite Pro was sold in New Jersey between January 2008 and November 2013.

In April 2012, the Food and Drug Administration warned USPLabs about the use of a dangerous stimulant called dimethylamylamine (“DMMA”) in its products. A class-action complaint followed and was resolved by a settlement agreement. Hogan v. USPLabs LLC, No. BC486925 (Cal. Super. Ct., L.A. County).

However, during and subsequent to Hogan v. USPLabs, LLC, Defendant USPLabs contained and or included another dangerous ingredient in OxyElite Pro called, Aegeline. Public health officials are currently investigating severe illnesses allegedly connected to Aegeline, including liver disease and hepatitis.

Plaintiff Barot points to medical records submitted to the FDA by the Hawaii Department of Health in which patients who used OxyElite Pro became severely ill. The complaint states that the use of the product was the only common factor among the patients and many became well again after stopping its use. Therefore, the complaint argues, the likelihood that OxyElite Pro caused the illnesses is strong.

While some consumers were lucky enough to get well after they ceased ingesting the dietary supplement, for others, the damage had already been done. Several patients sustained liver injuries that required transplantation. Tragically, one patient died before a transplant could be performed. As of February, OxyElite Pro has been linked to 97 cases of hepatitis.

On Oct. 11, 2013, the FDA issued a warning to USPLabs to stop distribution of all products containing aegeline. The company conducted a voluntary recall about one month later, but Barot says it failed to provide any notice to consumers.

Specifically, Barot says he and other potential class members suffered economic damage in buying USPLabs’ products, which they would not have taken had they known of aegeline’s potential adverse effects. He also alleges that inadequate labeling on the product constituted an unfair trade practice because the ingredients were unfit for safe use and that the defendant companies were unjustly enriched at the expense of consumers’ health.

Currently, at least 97 people have suffered severe hepatitis in connection with OxyElite Pro, and one person has died. The first reports of liver damage linked to OxyElite Pro came to light in May 2013, but the FDA was not aware of this until September of that year. Several months later, the manufacturer of OxyElite, USPLabs, issued a voluntary recall.

Scientists now believe that the questionable OxyElite ingredient, aegeline, is responsible for these cases of hepatitis, and the FDA has ordered USPLabs to discontinue its use.

Dr. Pieter Cohen of Harvard University published an article in The New England Journal of Medicine on this topic topic and explains that the hepatitis cases linked to OxyElite Pro are merely emblematic of a larger problem: the safety and efficacy of dietary supplements are not regulated by the FDA before products hit the shelves.

Cohen writes “The FDA’s delayed response — with its life-threatening consequences — is attributable to our woefully inadequate system for monitoring supplement safety. Americans spend more than $32 billion a year on more than 85,000 different combinations of vitamins, minerals, botanicals, amino acids, probiotics, and other supplement ingredients. Unlike prescription medications, supplements do not require premarketing approval before they reach store shelves. Under the Dietary Supplement Health and Education Act of 1994, anything labeled as a dietary supplement is assumed to be safe until proven otherwise. The FDA is charged with the unenviable task of identifying and removing dangerous supplements only after they have caused harm.”

He explains that in 2013 alone, his colleagues and FDA researchers identified two novel analogues of methamphetamine present in products currently available to consumers. One analogue was present in a sports drink, and the other analogue was present in nine dietary supplements. By law, none of these products were to be reviewed ad hoc by the FDA, a loophole in effect making lab animals out of consumers.

Though a US Senate bill sponsored by Dick Durbin (D-IL) and Richard Blumenthal (D-CT) is currently under review by committee that would ensure proper labeling of “vitamins, minerals, botanicals, probiotics, and other supplement ingredients,” Dr. Cohen states that this “would not improve the FDA’s ability to detect and remove dangerous supplements from store shelves.”

What is required is a more broadened reform of the approval processes for dietary supplements and other such products. It seems clear and obvious that anything consumed in our country should undergo rigorous testing before it becomes available on the market, particularly if a product advertises health benefits. While this could lengthen the time it takes before products may be sold and increase costs, any financial burden or wait time would be well worth the benefit of a more protected America.

To that end, Congress passed the Drug Quality and Security Act (DQSA) on 11/27/2013, a law with two aims: to ensure the quality of compounded drugs, and to ensure the security of compounded drugs. Toward the goal of ensuring drug quality, the law “Establishes annual registration requirement for any outsourcing facility” (for clarity, “outsourcing facility” means compounding pharmacy), “Requires a facility to report biannually to the Secretary of Health and Human Services (HHS) on what drugs are compounded in the facility and to submit adverse event reports”, and “Subjects such facilities to a risk-based inspection schedule.” (DQSA)

Toward the goal of ensuring drug security, the law “Establishes requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain” (DQSA). According to an article by FDA Commissioner Dr. Margaret Hamburg, this will be a stepwise process taking ten years to become fully effective. At that point, the law “will require manufacturers, repackagers, wholesale drug distributors, and dispensers (other than most licensed health care practitioners) to provide product and transaction information with each sale and notify the FDA and other stakeholders of illegitimate products, which will result in improved detection and removal of potentially dangerous drugs from the supply chain.”

Jill Wechsler, Washington editor of the Pharmaceutical Technology blog, PharmaTech Talk, writes that of yet (just three months after the passage of DQSA), only 14 compounding pharmacies have registered with the FDA – of over 3,000 currently operating in the United States. However, these figures ought not to be discouraging, she writes, as “this initial activity reflects FDA’s fast action in implementing the Drug Quality and Security Act”.

Further, there is a disincentive for compounding pharmacies to register with the FDA including significant fees and the obligation to submit to federal regulations and inspections, and Wechsler writes the FDA is currently implementing three strategies to encourage compounding pharmacy registration. First, the FDA is asking “hospitals to exert their purchasing power to compel compounders to embrace the new regulatory system” by sending letters to “hospitals urging them to pressure the compounding pharmacies they buy from to sign up as outsourcing facilities. Support for this approach was recently voiced by executives at the Premier hospital system, which purchases drugs for hundreds of hospitals.”

Next, Commissioner Hamburg has sent letters to state governors and “members of state boards of pharmacy and state health officials” touting the benefits of the Drug Quality and Security Act, seeking state assistance in “dealing with distant compounders that ship into a state.”

Though there are certain disincentives for compounding pharmacies to register with the FDA, it must be made clear the possibilities of their commercial benefit and legal protection await.

Lastly, the FDA is aiming to encourage compounding pharmacy registration by re-establishing Pharmacy Compounding Advisory Committee, which will make new regulations. The committee will likely be composed of “leading experts in the field” and “nonvoting representatives of pharmaceutical manufacturers and of pharmacy compounders.”

Wechsler concludes, “One important task for FDA is to develop lists of drugs that may not be compounded and lists of bulk drug substances that comply with established standards and thus may be used in compounding. FDA plans to issue new regulations to update these lists. The agency also will continue proactive and for-cause inspections of compounding pharmacies and will ‘take aggressive action’ when necessary to protect the public health.”

Though I find it incredible that compounding pharmacies had not as yet been subject to federal inspection and other such requirements, DQSA is absolutely a step in the right direction.

Yesterday (1/16/2014) Reuters reported that an FDA advisory panel rejected a call by Johnson and Johnson to approve their anticoagulant Xarelto (rivaroxaban) for acute coronary syndrome by a vote of 10-0 with one abstention.

While Xarelto “is already used to treat and prevent deep vein thrombosis and pulmonary embolisms and to reduce the risk of stroke and blood clots in patients with an irregular heart beat that is not caused by heart problems”, due to a lack of data and a failure by the company to demonstrate the benefits of Xarelto outweigh the risk for bleeding associated with the drug, the FDA advisory panel decided that “Xarelto should not be approved to prevent further heart problems in patients who have recently suffered a heart attack”.

If the drug had been approved for acute coronary syndrome, it could be prescribed for “any condition brought on by a sudden, reduced blood flow to the heart, including heart attack and chest pain.”

Sadly, it seems Johnson and Johnson made its case based on evidence from only one research study. Dr. Stephen Grant, consulting professor of medicine at Stanford University School of Medicine, gave an interview to Reuters, stating “Looking at the overall study it wasn’t robust enough in terms of statistical significance to be considered a positive study, and with that it was not possible to look at subgroups.”

“Dr. Stephen Grant, deputy director of the FDA’s division of cardiovascular and renal drugs, said the benefit of the drug met the criteria required to approve a drug based on a single trial – namely, proof it was superior in some way to existing products.”

Recent reports from MarketWatch and Bloomberg Businessweek cite that the US drug prices fell by about 1% last month, representing the largest such dip in prices in decades.

Interestingly, MarketWatch reported that the cost of drugs fell by 0.9%, and that this was the biggest monthly drop since 1969, and Bloomberg reported the cost fell by 0.8%, the largest decrease since 1967. Whatever the case may be, these are historic figures and allow a bit of fresh air for consumers in the US prescription drug market, what is widely-known for its high prices.

According to MarketWatch, “A so-called ‘patent cliff’ in which a number of exclusive rights expired on a number of top-selling drugs over the last year or two is the likely culprit for the prescription drug price drop.” These drugs included “Pfizer Inc.’s (PFE -0.05%) cholesterol-fighting superstar Lipitor, as well as the coronary treatment Plavix, sold by Bristol-Myers Squibb (BMY -0.35%) and Sanofi (SNY -0.21%).”

And, while these next two categories did not set records, the price over-the-counter drugs fell by an average of 0.9%, and the cost of medical devices fell by 0.5% last month, amounting to a 1.6% drop in cost since the same time last year for the latter category. (MarketWatch)

This comes as the Centers for Medicare and Medicaid Services (CMS) “issued a final rule today to ensure that Medicaid’s home and community-based services programs provide full access to the benefits of community living and offer services in the most integrated settings”, part of the Affordable Care Act, supporting HHS’s Community Living Initiative.

According to HHS, “Under the final rule, Medicaid programs will support home and community-based settings that serve as an alternative to institutional care and that take into account the quality of individuals’ experiences.” (hyperlink added)

HHS Secretary Kathleen Sebelius said “Today’s announcement will help ensure that all people participating in Medicaid home and community-based services programs have full access to the benefits of community living.” Hopefully she is right.

On Thursday, January 9th 2014, MedlinePlus reported that gene therapy may be helpful to patients suffering from advanced-stage Parkinson’s disease, as demonstrated by new research.

According to the researchers, this therapy, “called ProSavin, works by reprogramming brain cells to produce dopamine, the chemical essential for controlling movement”. (MedlinePlus)

This research comes from an English company, Oxford BioMedica, where lead researcher Kyriacos Mitrophanous is quoted, stating “We demonstrated that we are able to safely administer genes into the brain of patients and make dopamine, the missing agent in Parkinson’s patients”.

Patients with Parkinson’s, a disease characterized by insufficient dopamine in the brain, suffer deceased muscle control which may begin as a slight tremor, but “also commonly causes stiffness or slowing of movement.” (Mayo Clinic)

“‘The ProSavin study was a positive and important first step for a potential gene therapy for Parkinson’s disease,’ said Dr. Michael Okun, national medical director at the National Parkinson Foundation. ‘The results of this preliminary study revealed a promising safety profile, and it will be interesting to observe longer-term benefits and how ProSavin will compare to other therapies such as deep brain stimulation.’” (MedlinePlus)

While ProSavin has not yet proven itself more beneficial than levodopa, the mainstay in dopamine therapy for Parkinson’s disease, or deep brain stimulation, a technique for boosting dopamine production using electrical stimulation with wires and an external battery pack, gene therapy carries at least one theoretical advantage.

According to Mitrophanous, as the disease progresses over time, patients require more and more medication. With gene therapy, the body is “tricked,” if you will, into creating the dopamine it needs itself.

“Patients injected with ProSavin had mild to moderate side effects. The most common while on medication were involuntary movements (dyskinesias) and switching between mobility and immobility, called on-off phenomena, which occurs as levodopa wears off.” However, “All patients showed significant improvements in motor scores in the 12 hours after they stopped taking their other medications and at six months and a year after surgery, the researchers found.” (MedlinePlus)

About this Blog

This blog chronicles legal and scientific news relating to personal injuries caused by defective drugs and medical devices. It is published by injury lawyer Justinian C. Lane, an attorney who takes a personal interest in each of his clients’ cases.